The evaluation of a tailored intervention to improve the management of suspected viral encephalitis: protocol for a cluster randomised controlled trial

Abstract

BackgroundViral encephalitis is a devastating condition for which delayed treatment is associated with increased morbidity and mortality. Clinical audits indicate substantial scope for improved detection and treatment. Improvement strategies should ideally be tailored according to identified needs and barriers to change. The aim of the study is to evaluate the effectiveness and cost-effectiveness of a tailored intervention to improve the secondary care management of suspected encephalitis.Methods/DesignThe study is a two-arm cluster randomised controlled trial with allocation by postgraduate deanery. Participants were identified from 24 hospitals nested within 12 postgraduate deaneries in the United Kingdom (UK). We developed a multifaceted intervention package including core and flexible components with embedded behaviour change techniques selected on the basis of identified needs and barriers to change. The primary outcome will be a composite of the proportion of patients with suspected encephalitis receiving timely and appropriate diagnostic lumbar puncture within 12 h of hospital admission and aciclovir treatment within 6 h. We will gather outcome data pre-intervention and up to 12 months post-intervention from patient records. Statistical analysis at the cluster level will be blind to allocation. An economic evaluation will estimate intervention cost-effectiveness from the health service perspective.Trial registrationControlled Trials: ISRCTN06886935.Electronic supplementary materialThe online version of this article (doi:10.1186/s13012-014-0201-1) contains supplementary material, which is available to authorized users.

A pragmatic cluster randomised controlled trial of a tailored intervention to improve the initial management of suspected encephalitis

“…We conducted a cluster randomised controlled trial with National Health Service (NHS) postgraduate deaneries as the unit of randomisation [35]. Deaneries are responsible for postgraduate medical training.…”

“…The primary analysis fitted a generalised linear mixed model with binomial errors, logistic link, fixed effects for treatment (control versus intervention) and block (high or low level of previous involvement for the deanery in the ENCEPH UK research programme), and random effects for deanery and hospital [35]. Formally, if p btdh denotes the probability of a positive outcome (y = 1) in block b , treatment arm t , deanery d and hospital h , the model is that: where the U d are independent, Normally distributed with mean zero and variance and the V h are independent, Normally distributed with mean zero and variance .…”